Clinical Pharmacology & DMPK
Scientist I / Scientist II, Bioanalytical
Office Location: Madison, WI
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
Arrowhead Pharmaceuticals is seeking a Scientist I/II to join the BioAnalytical Development team within the Clinical Pharmacology and DMPK Department. The successful candidate will play a key role in the development and validation of bioanalytical ligand‑binding assays to support immunogenicity assessment (ADA), and in the execution of bioanalytical sample analysis across nonclinical, early‑ and late‑phase clinical programs. The candidate will also support internal data review and inventory management. The ideal candidate will have hands-on experience with Mesoscale Discovery (MSD) and various analytical platforms, along with a strong foundation in GxP bioanalysis. The individual will join a team of highly motivated and experienced scientists and will contribute directly to the success of Arrowhead’s therapeutic programs.
Responsibilities
- Work independently or in collaboration with senior scientists to support project planning for bioanalytical activities, including critical reagent generation and the ADA method development, optimization, and qualification.
- Lead assigned projects, perform or oversee non-GxP and GxP ADA validations and sample analysis from early to late development, both internally and with external partners. Conduct data analysis and interpretation as needed.
- Track progress against project timelines, prepare routine status updates, and effectively communicate progress, challenges, and mitigations to management and cross‑functional project teams.
- Collaborate and support internal bioanalysis team on data review and inventory management
- Stay current with evolving methodologies, and regulatory expectations related to ADA assessment, particularly for oligonucleotide therapeutics.
- Manage multiple projects concurrently and prioritize work effectively in a fast‑paced environment.
Requirements
- Bachelor’s degree with 5+ years, or Master’s degree with 3+ years, of relevant experience in the pharmaceutical or CRO industry.
- Demonstrated experience in method development using diverse analytical platforms, with deep expertise in ligand‑binding assays for immunogenicity assessment.
- Proven project‑management skills with the ability to prioritize multiple tasks and meet deadlines.
- Strong organizational skills with excellent attention to detail, and adherence to good documentation practices.
- Excellent oral and written communication skills.
- Self‑motivated team player who thrives in a fast-paced, dynamic, multidisciplinary, and matrixed environment.
Preferred
- Hands-on experience with a range of analytical platforms, including MSD, ELISA, Gyros, Luminex, LC-FL, and qPCR etc., ideally within the context of oligonucleotide therapeutics.
- Experience and familiarity with GxP regulations and industry best practices for method validation, sample handling, and bioanalytical workflows.
- Experience with electronic laboratory notebooks and LIMS.
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.